Phase 3
Completed N=185
Safety and Tolerability of Conversion From Oral, Injectable, or Infusion Disease Modifying Therapies to Dose-titrated Oral Siponimod (Mayzent) in Advancing RMS Patients
Multiple Sclerosis · Advancing Multiple Sclerosis
Source: ClinicalTrials.gov NCT03623243 ↗
Enrolled (actual)
185
Serious AEs
4.9%
Results posted
Jul 2023
Primary outcomePrimary: Number of Participants With at Least One Treatment-emergent Adverse Event (TEAE) Related to Study Drug During the Treatment Period — 59 Participants
◆ Published Evidence
Emerging
1citation · ~1 / year
Safety and tolerability of conversion to siponimod from other disease-modifying therapies in patients with advancing forms of relapsing MS: Results from the EXCHANGE study.
Summary
To assess safety and tolerability of patients converting from approved Relapsing Multiple Sclerosis (RMS) Disease Modifying Therapies (DMTs) to siponimod.
Linked Publications
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Safety and tolerability of conversion to siponimod from other disease-modifying therapies in patients with advancing forms of relapsing MS: Results from the EXCHANGE study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With at Least One Treatment-emergent Adverse Event (TEAE) Related to Study Drug During the Treatment Period |
59 | — |
| SECONDARY Number of Participants With at Least One Adverse Event (AE) |
138 | — |
| SECONDARY Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM-9) |
13.5; 15.6; 15.3 | — |
| SECONDARY Change in Heart Rate From Baseline to 6 Hours After First Treatment |
2.47 | — |
| SECONDARY Number of Participants With at Least One Hospitalization During the Treatment |
9 | — |
| SECONDARY Patient Retention Reported as Number of Participants Who Completed the Study |
146 | — |
Eligibility Criteria
Key Inclusion Criteria
- Signed informed consent.
- Male or female aged 18 to 65 years (inclusive).
- Patients with advancing RMS as defined by the principal investigator.
- Prior history of relapsing MS (RMS), with or without progressive features, according to the 2010 Revised McDonald or Lublin criteria (Lublin et al, 2013).
- EDSS score of >/= 2.0 to 6.5 (inclusive).
- Having been continuously treated with RMS Disease Modifying Therapies.
Key Exclusion criteria
- Pregnant or nursing (lactating) women.
- Patients with any medically unstable condition as determined by the investigator.
- Certain cardiac risk factors defined in the protocol
- History of hypersensitivity to the study drug or to drugs of similar chemical classes.
Other protocol-defined inclusion/exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT03623243) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.